The NMPA granted innovation approvals to two devices on June 20, 2023.
- Zap Surgical: Head and neck X-ray stereotactic radiosurgery system
- Beijing Shurui: Laparoscopic single-port robotic surgical system
There have been 217 innovation devices approved since 2014. To get an English copy of innovation devices catalog, please email info@ChinaMedDevice.com.
We have translated the Innovation Device Approval Procedure for you, available for download.
What are the Devices
Head and neck X-ray stereotactic radiosurgery system
The product consists of 3MV medical linear accelerator, tilt axis and vertical axis frame, X-ray high-pressure generator, X-ray tube assembly, X-ray detector, treatment bed, air compressor, main power supply, auxiliary power supply, water cooling system, suspended console, operator console, treatment planning software for radiation therapy of intracranial and cervical solid malignancies and lesions.
The self-shielding structure design of the product limits the radiation level to an acceptable safety threshold, reduces the construction cost of the hospital computer room, eliminates the need to build a protective wall, and accelerates the product installation cycle.
The tungsten wheel collimator and optimized linear accelerator ensure high dose accuracy, reduce radiation leakage, minimize radiation beam penumbra, enable more radiation dose to reach the tumor area, and reduce the amount of radiation to normal tissues around the tumor, which has certain clinical advantages.
Laparoscopic single-port surgery system
The product is composed of doctor’s console, patient operating platform, three-dimensional electronic endoscope, surgical instruments, and accessories, which is used for laparoscopic surgery operation in urology, and is the first endoscopic single-port surgery system in China, effectively filling the domestic gap.
The surgical instruments in this product adopt the innovative technology of the international first and independent intellectual property rights and have the technical advantages of wide range of motion, strong load capacity and high reliability.
The product is operated in a single-port manner, the endoscope and surgical instruments have multiple active degrees of freedom, only the movement of the surgical instruments in the patient’s abdominal cavity can complete the surgical operation, and the external positioning arm remains stationary during remote operation, avoiding the risk of collision during surgery. Control with its unique control system improves operator refinement and reduces surgical trauma.